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41. Tildrakizumab (Ilumetri) - treatment of adults with moderate to severe plaque psoriasis

Tildrakizumab (Ilumetri) - treatment of adults with moderate to severe plaque psoriasis Published 12 August 2019 1 SMC2167 tildrakizumab 100mg solution for injection in pre- filled syringe (Ilumetri®) Almirall Limited 5 July 2019 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows: ADVICE: following a full submission (...) tildrakizumab (Ilumetri ® ) is accepted for restricted use within NHSScotland. Indication under review: The treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. SMC restriction: for use in patients who have failed to respond to conventional systemic therapies (including ciclosporin, methotrexate and phototherapy), are intolerant to, or have a contraindication to these treatments. Tildrakizumab was superior to placebo in improving the signs and symptoms

2019 Scottish Medicines Consortium

42. Risankizumab (Skyrizi) - plaque psoriasis

Risankizumab (Skyrizi) - plaque psoriasis 1 Published 07 October 2019 1 SMC2196 risankizumab 75mg solution for injection in pre-filled syringe (Skyrizi®) AbbVie Ltd 06 September 2019 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows: ADVICE: following a full submission risankizumab (Skyrizi ® ) is accepted for restricted (...) use within NHSScotland. Indication under review: for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. SMC restriction: for patients who have failed to respond to conventional systemic therapies (including ciclosporin, methotrexate and phototherapy), are intolerant to, or have a contraindication to these treatments. Risankizumab was superior to placebo, a tumour necrosis factor antagonist, and an interleukin 12/23 antagonist in improving

2019 Scottish Medicines Consortium

43. Certolizumab pegol (Cimzia) - the treatment of moderate to severe plaque psoriasis

Certolizumab pegol (Cimzia) - the treatment of moderate to severe plaque psoriasis 1 Published 08 April 2019 1 SMC2132 certolizumab pegol 200mg solution for injection in pre-filled syringe and pen (Cimzia®) UCB Pharma Ltd 8 March 2019 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows: ADVICE: following a full submission (...) certolizumab pegol (Cimzia ® ) is accepted for restricted use within NHSScotland. Indication under review: the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy SMC restriction: patients who have failed to respond to standard systemic therapies (including ciclosporin, methotrexate and phototherapy), are intolerant to, or have a contra- indication to these treatments. Certolizumab pegol has shown a similar reduction in the signs and symptoms of psoriasis

2019 Scottish Medicines Consortium

44. Secukinumab (plaque psoriasis) - Benefit assessment according to §35a Social Code Book V (new scientific findings)

Secukinumab (plaque psoriasis) - Benefit assessment according to §35a Social Code Book V (new scientific findings) Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Secukinumab (Plaque-Psoriasis) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 May 2017). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission (...) No. A17-08 Secukinumab (plaque psoriasis) – Benefit assessment according to §35a Social Code Book V 1 (new scientific findings) Extract of dossier assessment A17-08 Version 1.0 Secukinumab (plaque psoriasis) 30 May 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Secukinumab (plaque psoriasis) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

45. Ixekizumab (plaque psoriasis) - Addendum to Commission A17-07

Ixekizumab (plaque psoriasis) - Addendum to Commission A17-07 1 Translation of addendum A17-30 Ixekizumab (Plaque Psoriasis) – Addendum zum Auftrag A17-07 (Version 1.0; Status: 28 July 2017). Please note: This translation is provided as a service by IQWiG to English- language readers. However, solely the German original text is absolutely authoritative and legally binding. Addendum 28 July 2017 1.0 Commission: A17-30 Version: Status: IQWiG Reports – Commission No. A17-30 Ixekizumab (plaque (...) psoriasis) – Addendum to Commission A17-07 1 Addendum A17-30 Version 1.0 Ixekizumab – Addendum to Commission A17-07 28 July 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Ixekizumab (plaque psoriasis) – Addendum to Commission A17-07 Commissioning agency: Federal Joint Committee Commission awarded on: 11 July 2017 Internal Commission No.: A17-30 Address of publisher: Institut für Qualität und

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

46. [Dimethyl fumarate (psoriasis) - benefit assessment according to õ35a Social Code Book V]

[Dimethyl fumarate (psoriasis) - benefit assessment according to õ35a Social Code Book V] Dimethylfumarat (psoriasis vulgaris): nutzenbewertung gemäß § 35a SGB V; dossierbewertung; auftrag A17-49 [Dimethyl fumarate (psoriasis) - benefit assessment according to §35a Social Code Book V] Dimethylfumarat (psoriasis vulgaris): nutzenbewertung gemäß § 35a SGB V; dossierbewertung; auftrag A17-49 [Dimethyl fumarate (psoriasis) - benefit assessment according to §35a Social Code Book V] Institut für (...) Qualität und Wirtschaftlichkeit im Gesundheitswesen Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen. Dimethylfumarat (psoriasis vulgaris): nutzenbewertung gemäß § 35a SGB V; dossierbewertung; auftrag A17-49. [Dimethyl fumarate (psoriasis) - benefit assessment according to §35a

2018 Health Technology Assessment (HTA) Database.

47. [Brodalumab (plaque psoriasis) - benefit assessment according to õ35a Social Code Book V]

[Brodalumab (plaque psoriasis) - benefit assessment according to õ35a Social Code Book V] Brodalumab (Plaque-Psoriasis): nutzenbewertung gemäß § 35a SGB V; dossierbewertung; auftrag A17-42; version 1.1 [Brodalumab (plaque psoriasis) – benefit assessment according to §35a Social Code Book V] Brodalumab (Plaque-Psoriasis): nutzenbewertung gemäß § 35a SGB V; dossierbewertung; auftrag A17-42; version 1.1 [Brodalumab (plaque psoriasis) – benefit assessment according to §35a Social Code Book V (...) ] Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen. Brodalumab (Plaque-Psoriasis): nutzenbewertung gemäß § 35a SGB V; dossierbewertung; auftrag A17-42; version 1.1. [Brodalumab (plaque psoriasis) – benefit assessment

2018 Health Technology Assessment (HTA) Database.

48. Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people: systematic review and economic evaluation

Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people: systematic review and economic evaluation Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people: systematic review and economic evaluation Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people: systematic review and economic evaluation Duarte A, Mebrahtu T, Goncalves P S, Harden M, Murphy R, Palmer S, Woolacott (...) N, Rodgers M & Rothery C. Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation Duarte A, Mebrahtu T, Goncalves P S, Harden M, Murphy R, Palmer S, Woolacott N, Rodgers M & Rothery C.. Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people: systematic review and economic evaluation. Health Technology

2018 Health Technology Assessment (HTA) Database.

49. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis. Full Text available with Trip Pro

Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis. Psoriasis is an immune-mediated disease for which some people have a genetic predisposition. The condition manifests in inflammatory effects on either the skin or joints, or both, and it has a major impact on quality of life. Although there is currently no cure for psoriasis, various treatment strategies allow sustained control of disease signs and symptoms. Several randomised controlled trials (RCTs (...) ) have compared the efficacy of the different systemic treatments in psoriasis against placebo. However, the relative benefit of these treatments remains unclear due to the limited number of trials comparing them directly head to head, which is why we chose to conduct a network meta-analysis.To compare the efficacy and safety of conventional systemic agents (acitretin, ciclosporin, fumaric acid esters, methotrexate), small molecules (apremilast, tofacitinib, ponesimod), anti-TNF alpha (etanercept

2017 Cochrane

50. Single-center, noninterventional clinical trial to assess the safety, efficacy, and tolerability of a dimeticone-based medical device in facilitating the removal of scales after topical application in patients with psoriasis corporis or psoriasis capitis Full Text available with Trip Pro

Single-center, noninterventional clinical trial to assess the safety, efficacy, and tolerability of a dimeticone-based medical device in facilitating the removal of scales after topical application in patients with psoriasis corporis or psoriasis capitis Psoriasis is a frequent inflammatory skin disease affecting ~2%-3% of the population in western countries. Scaling of the psoriatic lesions is the most impairing symptom in patients with psoriasis. In contrast to conventional keratolytic (...) treatment concepts containing salicylic acid or urea, a dimeticone-based medical device (Loyon®) removes scales in a physical way without any pharmacological effect.To assess the efficacy and tolerability of a dimeticone-based medical device in removal of scales in patients with psoriasis corporis/capitis under real-life conditions.Forty patients with psoriasis capitis or corporis were included and received once-daily treatments for 7 days. Clinical assessment of the psoriasis area severity index score

2017 Psoriasis (Auckland, N.Z.)

51. Genetic polymorphisms associated with psoriasis and development of psoriatic arthritis in patients with psoriasis. Full Text available with Trip Pro

Genetic polymorphisms associated with psoriasis and development of psoriatic arthritis in patients with psoriasis. Psoriasis (PsO) is a chronic inflammatory disease with predominantly cutaneous manifestations. Approximately one third of patients with PsO develop psoriatic arthritis (PsA), whereas the remaining proportion of patients has isolated cutaneous psoriasis (PsC). These two phenotypes share common immunology, but with different heredity that might in part be explained by genetic (...) and development of PsA in PsO.Eleven polymorphisms in 10 genes were nominally associated with PsO and/or PsC and/or PsA (P < 0.05). After correction for multiple testing with a false discovery rate of 5%, two SNPs remained significant: TNF (rs361525) was associated with PsO, PsC10, and PsA; and IL12B (rs6887695) was associated with PsO.Among a cohort of Danish patients with moderate-to-severe psoriasis, two SNPs in the IL12B and TNF genes were associated with susceptibility of psoriasis. None of the SNPs were

2018 PLoS ONE

52. Targeted Immunomodulators for the Treatment of Moderate-to-Severe Plaque Psoriasis: Effectiveness and Value

Targeted Immunomodulators for the Treatment of Moderate-to-Severe Plaque Psoriasis: Effectiveness and Value ©Institute for Clinical and Economic Review, 2018 Targeted Immunomodulators for the Treatment of Moderate-to-Severe Plaque Psoriasis: Effectiveness and Value Condition Update Evidence Report June 12, 2018 Prepared for: ©Institute for Clinical and Economic Review, 2018 Page i Evidence Report: Targeted Immunomodulators for Plaque Psoriasis | Condition Update ICER Staff/Consultants (...) Immunomodulators for Plaque Psoriasis | Condition Update About ICER The Institute for Clinical and Economic Review (ICER) is an independent non-profit research organization that evaluates medical evidence and convenes public deliberative bodies to help stakeholders interpret and apply evidence to improve patient outcomes and control costs. The funding for this report comes from government grants and non-profit foundations, with the largest single funder being the Laura and John Arnold Foundation. No funding

2018 California Technology Assessment Forum

53. Guselkumab (Tremfya) - Treatment of moderate to severe plaque psoriasis

Guselkumab (Tremfya) - Treatment of moderate to severe plaque psoriasis Published 11 June 2018 1 guselkumab 100mg solution for injection (Tremfya ® ) SMC No 1340/18 Janssen 4 May 2018 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHS Scotland. The advice is summarised as follows: ADVICE: following a full submission guselkumab (Tremfya ® ) is accepted for restricted (...) use within NHS Scotland. Indication under review: Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. SMC restriction: for patients who have failed to respond to conventional systemic therapies (including ciclosporin, methotrexate and phototherapy), are intolerant to, or have a contraindication to these treatments. In two phase III studies, guselkumab was superior to a TNF inhibitor in improving symptoms of moderate to severe plaque psoriasis

2018 Scottish Medicines Consortium

54. Brodalumab (Kyntheum) - for the treatment of moderate to severe plaque psoriasis

Brodalumab (Kyntheum) - for the treatment of moderate to severe plaque psoriasis Published 7 May 2018 1 Re-Submission brodalumab 210mg solution for injection in pre-filled syringe (Kyntheum ® ) SMC No 1283/17 Leo Laboratories Ltd 6 April 2018 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHS Scotland. The advice is summarised as follows: ADVICE: following (...) a resubmission brodalumab (Kyntheum ® ) is accepted for restricted use within NHS Scotland. Indication under review: for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy. SMC restriction: for patients who have failed to respond to standard systemic therapies (including ciclosporin, methotrexate and phototherapy), are intolerant to, or have a contra-indication to these treatments. Brodalumab was superior to placebo and to an alternative interleukin

2018 Scottish Medicines Consortium

55. Etanercept (Erelzi) - rheumatoid arthritis, juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, axial spondyloarthritis

Etanercept (Erelzi) - rheumatoid arthritis, juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, axial spondyloarthritis 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. 21 April 2017 EMA (...) Kilogram MAA Marketing Authorisation Application mg Milligram MMRM Mixed Model Repeated Measure N Na ns Number of Patients Not analysed Not specified PASI Psoriasis Area and Severity Index PC Placebo-controlled PD Pharmacodynamics PK Pharmacokinetics PPS Per-protocol set RA Rheumatoid arthritis SAE Serious Adverse Event SAP Statistical Analysis Plan SD SDV Standard deviation Source Data Verification SmPC Summary of Product Characteristics sTNF soluble Tumour Necrosis Factor TEAE Treatment-emergent

2017 European Medicines Agency - EPARs

56. Dimethyl fumarate (Skilarence) - plaque psoriasis

Dimethyl fumarate (Skilarence) - plaque psoriasis 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. 21 April 2017 EMA/412737/2017 Committee for Medicinal Products for Human Use (CHMP) Assessment report Skilarence International non (...) of quantification LOCF Last observation carried forward LS mean Least square mean MAA Marketing Authorisation Application MTX Methotrexate MedDRA Medical Dictionary for Regulatory Activities MEF Monoethyl fumarate (synonym: ethyl hydrogen fumarate) MHRA Medicines & Healthcare Products Regulatory Agency MMF Monomethyl fumarate NF-?B Nuclear factor ‘kappa-light-chain-enhancer of activated B-cells’ PASI Psoriasis Area and Severity Index PBI Patient Benefit Index PBQ Patient Benefit Questionnaire PD

2017 European Medicines Agency - EPARs

57. Guselkumab (Tremfya) - For the treatment of adult patients with moderate-to-severe plaque psoriasis

Guselkumab (Tremfya) - For the treatment of adult patients with moderate-to-severe plaque psoriasis TREMFYA (guselkumab) Injection U.S. Department of Health and Human Services Search FDA Submit search TREMFYA (guselkumab) Injection TREMFYA Company: Janssen Biotech, Inc. Application No.: 761061 Approval Date: 07/13/2017 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) Date created

2017 FDA - Drug Approval Package

58. Enstilar (calcipotriol + betamethasone) - for the treatment of psoriasis

Enstilar (calcipotriol + betamethasone) - for the treatment of psoriasis Enstilar® (calcipotriol + betamethasone) × Insert searchphrase to search the website Insert searchphrase to search the website > > > Enstilar® (calcipotriol + betamethasone) Conclusion Enstilar is a combination product containing calcipotriol and betamethasone for the treatment of psoriasis of the body and scalp. Enstilar is a cutaneous foam. Enstilar is more effective than both placebo and treatment with either (...) of the active substances alone. It has not been investigated if Enstilar is more effective than concurrent treatment with the two monoproducts. In the treatment of psoriasis of the body, Enstilar is more effective than corresponding combination products with an NNT of respectively 9 compared to ointment and respectively 6 compared to gel and does not cause more adverse reactions. Enstilar has not been compared to corresponding combination products in the treatment of psoriasis of the scalp. Generally

2017 Danish Pharmacotherapy Reviews

59. Adalimumab (Imraldi) - psoriasis, psoriatic arthritis, axial spondyloarthritis, Crohn?s disease, ulcerative colitis

Adalimumab (Imraldi) - psoriasis, psoriatic arthritis, axial spondyloarthritis, Crohn?s disease, ulcerative colitis 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. 22 June 2017 EMA/CHMP/559383/2017 Committee for Medicinal Products (...) ) %AUC extrap The effect of extrapolated area PPS1 Per-protocol set 1 (Week 0 – Week 24) PPS2 Per-protocol set 1 (Week 24 – Week 52) PsA Psoriatic arthritis PsO Psoriasis PVR Process Validation Run QC Quality Control QL Quantitation Limit R Accumulation ratio RA Rheumatoid arthritis RAN Randomized set RS Reference standard RSD Relative Standard Deviation RT Reverse Transcription RT Room Temperature SAF Safety set SAP Statistical analysis plan SAR Structure Activity Relationship SAWP Scientific Advice

2017 European Medicines Agency - EPARs

60. Dimethyl fumarate (Skilarence) - plaque psoriasis

Dimethyl fumarate (Skilarence) - plaque psoriasis Published 9 April 2018 1 dimethyl fumarate 30mg and 120mg gastro-resistant tablets (Skilarence ® ) SMC No 1313/18 Almirall Limited 9 March 2018 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHS Scotland. The advice is summarised as follows: ADVICE: following a full submission dimethyl fumarate (Skilarence ® (...) ) is accepted for restricted use within NHS Scotland. Indication under review: for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy. SMC restriction: for use in patients in whom other non-biologic systemic treatments (methotrexate, ciclosporin and acitretin) are not appropriate or have failed and who are considered unsuitable for biologic therapy given their current disease state or personal preference. In a 16 week, double-blind, phase III study, dimethyl

2018 Scottish Medicines Consortium

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